Effect of Propofol and Sevoflurane on Lactate During Anesthesia for Pediatric Heart Catheterisation (PRISCATHLAB)

University Hospital Schleswig-Holstein (UKSH)

Status: Completed

Conditions: Metabolic Acidosis

Treatments: Drug: Propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT01293266

Fudickar2

Details and patient eligibility

About

Propofol is routinely used for general anesthesia during pediatric heart catheterisation. Propofol infusion syndrome (PRIS) is a rare, but often fatal complication mainly defined by bradycardia with progress to asystolia during propofol infusion. Metabolic acidosis is regarded as an early warning sign of PRIS. In this study the effect of propofol and sevoflurane on serum base excess, pH and lactate are examined during pediatric heart catheterisation.

Full description

In this prospective randomised study 40 children are anesthetised for pediatric heart catheterisation with propofol (N = 22) or sevoflurane (N = 18) with ethic committee approval. Base excess, pH and lactate were measured by blood gas analysis at the beginning, during and at the end of the procedure. Changes relative to baseline were analysed by paired t-Test with correction for multiple testing. The study was powered to detect a difference of 1.5 mmol/l for base excess and lactate.

Enrollment: 40 patients

Sex: All

Ages: Under 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Indication for heart catheterization under general anesthesia

Exclusion criteria

• Participation in another study
• Preexisting metabolic acidosis
• Contraindication against Propofol

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Propofol

Active Comparator group

Description:

Anesthesia is changed from Sevoflurane to Propofol after obtaining baseline blood gas analysis from the heart catheterisation sheath.

Treatment:

Drug: Propofol

Sevoflurane

No Intervention group

Description:

Sevoflurane anesthesia is maintained after obtaining a baseline blood gas analysis.